The following data is part of a premarket notification filed by Luther Medical Products, Inc. with the FDA for Subclavian Jugular Catheter Set.
Device ID | K820102 |
510k Number | K820102 |
Device Name: | SUBCLAVIAN JUGULAR CATHETER SET |
Classification | Cannula, Catheter |
Applicant | LUTHER MEDICAL PRODUCTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | DQR |
CFR Regulation Number | 870.1300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-01-15 |
Decision Date | 1982-01-29 |